Back to resultsRehabTouch Home Therapy for Stroke Patients
Primary Purpose
Cerebral Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RehabTouch
Conventional tabletop exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke
Eligibility Criteria
Inclusion Criteria:
- Age: 18 to 85 years old
- Upper extremity weakness measured by a clinical scale
- Absence of moderate to severe pain on affected upper extremity
- Able to understand the instructions to operate RehabTouch
Exclusion Criteria:
- Concurrent severe medical problems, visual deficits, severe neglect or apraxia
- Enrollment to other therapy studies
Sites / Locations
- Rancho Research Institute, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RehabTouch Exercise Program
Conventional tabletop exercise program
Arm Description
Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.
Outcomes
Primary Outcome Measures
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.
Secondary Outcome Measures
Change in Box and Blocks Test Score
The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short duration.
Motor Activity Log
The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.
Visual Analog Pain Scale
A standard analog scale that ranges from 0 to 10 for assessing pain.
Modified Ashworth Spasticity Scale
The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.
Full Information
NCT ID
NCT03503617
First Posted
April 11, 2018
Last Updated
January 10, 2022
Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
Rancho Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03503617
Brief Title
RehabTouch Home Therapy for Stroke Patients
Official Title
RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
Rancho Research Institute, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RehabTouch Exercise Program
Arm Type
Experimental
Arm Description
Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
Arm Title
Conventional tabletop exercise program
Arm Type
Active Comparator
Arm Description
Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
RehabTouch
Other Intervention Name(s)
FitMi
Intervention Description
Exercise using the motion sensing devices and a computer
Intervention Type
Other
Intervention Name(s)
Conventional tabletop exercise program
Intervention Description
Exercise following printed sheets of exercises
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
Description
The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.
Time Frame
From Baseline to One-month Post-therapy
Secondary Outcome Measure Information:
Title
Change in Box and Blocks Test Score
Description
The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Time Frame
From Baseline to One-month Post-therapy
Title
10 Meter Walk Test
Description
The 10MWT assesses walking speed in meters per second over a short duration.
Time Frame
From Baseline to One-month Post-therapy
Title
Motor Activity Log
Description
The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.
Time Frame
One-month Post-therapy
Title
Visual Analog Pain Scale
Description
A standard analog scale that ranges from 0 to 10 for assessing pain.
Time Frame
From Baseline to One-month Post-therapy
Title
Modified Ashworth Spasticity Scale
Description
The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.
Time Frame
From Baseline to One-month Post-therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 to 85 years old
Upper extremity weakness measured by a clinical scale
Absence of moderate to severe pain on affected upper extremity
Able to understand the instructions to operate RehabTouch
Exclusion Criteria:
Concurrent severe medical problems, visual deficits, severe neglect or apraxia
Enrollment to other therapy studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Shaw, MD
Organizational Affiliation
Rancho Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Research Institute, Inc.
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RehabTouch Home Therapy for Stroke Patients
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